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Abstract

The use of animal-origin components and media in the commercial production of clostridial antigens for veterinary vaccine manufacture constitutes an unnecessary and excessive risk to food safety and health. For over 70 years, bacterial strains of the genus Clostridium have been used in the manufacture of veterinary and human vaccines to prevent infection and death. The vast majority of these products are made using animal-based components, including brain, heart and liver infusions, meat peptones and casein digests. Over the last twenty years, the threat of Transmissible Spongiform Encephalopathy (TSE) and adventitious oncogenic viral transmission has generated a significant concern about the safety and reliability of animal-based products. While many animal-free options have been developed in recent years, few manufacturers have adapted vaccine production processes to incorporate such media, primarily due to monetary costs, regulatory restrictions, and corporate inertia. Several manufacturers have made progress on the transition from animal-based to plant-based medias to reduce the TSE risk, but the majority of clostridial vaccines manufactured worldwide are still in animal-based media. While the regulatory agencies responsible for overseeing the human pharmaceutical and vaccine manufacturers have been aggressive in requiring the removal of animal-based components from the products, the animal health regulatory bodies have been slower to follow suit. A rapid and aggressive shift in policy is needed to provide the necessary changes to eliminate the risk of TSE from the livestock vaccine industry.